Back to resultsSPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCIO-469
SCIO-469
Placebo
SCIO-469
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, DMARDs, Methotrexate, p38 kinase
Eligibility Criteria
Inclusion Criteria: Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs) Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study Exclusion Criteria: Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months Lab tests revealed elevated liver enzymes within the past 6 months Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy HIV positive Abnormal electrocardiogram Chronic or acute infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
001
002
003
004
Arm Description
SCIO-469 30 mg capsule three times daily for 12 weeks
SCIO-469 60 mg capsule three times daily for 12 weeks
SCIO-469 100 mg tablet once daily for 12 weeks
Placebo 2 capsules three times daily and one tablet daily
Outcomes
Primary Outcome Measures
ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)
Secondary Outcome Measures
ACR50 responders at Week 12
ACR20 and ACR50 responders at each evaluation visit other than Week 12
All individual variables of the ACR response criteria at each evaluation visit
Disease Activity Score (DAS)28 at each evaluation visit.
The number of participants experiencing adverse events (AEs) as a measure of safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00089921
Brief Title
SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
Official Title
A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Scios, Inc.
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).
Detailed Description
This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, DMARDs, Methotrexate, p38 kinase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
SCIO-469 30 mg capsule three times daily for 12 weeks
Arm Title
002
Arm Type
Experimental
Arm Description
SCIO-469 60 mg capsule three times daily for 12 weeks
Arm Title
003
Arm Type
Experimental
Arm Description
SCIO-469 100 mg tablet once daily for 12 weeks
Arm Title
004
Arm Type
Placebo Comparator
Arm Description
Placebo 2 capsules three times daily and one tablet daily
Intervention Type
Drug
Intervention Name(s)
SCIO-469
Intervention Description
60 mg capsule three times daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
SCIO-469
Intervention Description
30 mg capsule three times daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 capsules three times daily and one tablet daily
Intervention Type
Drug
Intervention Name(s)
SCIO-469
Intervention Description
100 mg tablet once daily for 12 weeks
Primary Outcome Measure Information:
Title
ACR20 is 20% reduction in tender and swollen joint counts and 20% improvement in three of the five remaining ACR core set measures: patient and physician global assessments, visual analog scale for pain, HAQ, and an acute-phase reactant (CRP or ESR)
Time Frame
Day 1 to approximately Day 85 of treatment
Secondary Outcome Measure Information:
Title
ACR50 responders at Week 12
Time Frame
12 weeks
Title
ACR20 and ACR50 responders at each evaluation visit other than Week 12
Time Frame
24 weeks
Title
All individual variables of the ACR response criteria at each evaluation visit
Time Frame
24 weeks
Title
Disease Activity Score (DAS)28 at each evaluation visit.
Time Frame
24 Weeks
Title
The number of participants experiencing adverse events (AEs) as a measure of safety
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs)
Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study
Exclusion Criteria:
Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
Lab tests revealed elevated liver enzymes within the past 6 months
Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy
HIV positive
Abnormal electrocardiogram
Chronic or acute infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scios, Inc. Clinical Trial
Organizational Affiliation
Scios, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
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